FDA converts lecanemab to traditional approval

Lecanemab represents the first antibody treatment for Alzheimer’s disease to have received traditional approval from the Food and Drug Administration in the US.

On 6 July, the Food and Drug Administration (FDA) in the US approved lecanemab (Leqembi) through the traditional approval pathway for those living with mild cognitive impairment or the mild dementia stage of Alzheimer’s disease.

Lecanemab had previously been granted accelerated approval by the FDA, but this is the first time that an antibody treatment for Alzheimer’s disease has received traditional approval from the FDA, allowing it to remain on the market in the US.

ADI CEO, Paola Barbarino was also pleased to learn of the news and the potential for new developments in the sector, but noted that it may not be suitable for everyone:

Today is a ground-breaking day for people living with dementia and Alzheimer’s and their families. This solution will not work for everyone and is still too expensive for too many, but a door is opening at last on a new world of treatments that will revolutionise the way we see the condition. We hope it will also bring new funding for research and development and new brains to this difficult challenge, because there is still a long way to go to find a cure that works and that is safe for everyone. We at ADI will continue to work super hard to make sure our future will be one where we do not fear this terrible disease and condition any longer.

The granting of traditional approval by the FDA had been widely anticipated, following the FDA Advisory Committee voting unanimously to confirm the clinical benefit of lecanemab for the treatment of Alzheimer’s disease on 6 June 2023. The FDA has improved safety warnings on the labelling for lecanemab and has suggested testing for ApoE ε4 status prior to treatment. The updated language also includes cautions on its use for patients at risk of cerebral haemorrhage and ongoing monitoring, in the form of registries.

On the news, Emily Ong, an advocate who is a member of ADI’s Board and living with dementia was positive about the development. However, she cautioned that safety of those living with dementia should be the most important factor:

To many of those living with early Alzheimer’s disease or mild cognitive impairment, having FDA approved treatment options and access at time of diagnosis, makes a significant difference to the overall outlook of their lives with Alzheimer’s disease. The extra months or years of independence not only have personal meaningfulness to the individuals but also benefit their carers and family members. However, patient safety is the highest priority, and regular monitoring has to be put in place to ensure proper safe administration and treatment in real-life clinical practice.

Although welcome news, ADI is keen to hear more about access to the treatment, cost and affordability. We understand that the treatment will now be made available in the US by the Centres for Medicare & Medicaid Services (CMS), following their previously controversial decision last year to restrict access to all treatments that target amyloid for Alzheimer’s disease until traditional approval had been granted. More broadly, the approval highlights the necessity to address health system readiness within the US and across the globe to accommodate new medications such as lecanemab, a critical area of consideration that ADI has been highlighting for many years in its advocacy work.

ADI is awaiting further news from Eisai and Biogen on their plans to file regulatory approval in other countries, including the European Medicines Agency (EMA). There are further considerations necessary for countries where health systems are still being developed, especially those in low- and middle-income countries, where a confirmatory diagnosis with a positron emission tomography (PET) scan by a specialist might not be possible or feasible.

ADI will continue to provide further updates as and when they are available.



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